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Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

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Seagen

Status and phase

Terminated
Phase 2

Conditions

Transformed Lymphoma / DLBCL
Diffuse, Large B-Cell, Lymphoma
Follicular Lymphoma, Grade 3b

Treatments

Drug: prednisone
Drug: denintuzumab mafodotin
Drug: rituximab
Drug: doxorubicin
Drug: cyclophosphamide
Drug: vincristine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02855359
SGN19A-004

Details and patient eligibility

About

This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.

Full description

In Part A of the study, patients will be randomized 1:1 to receive denintuzumab mafodotin plus RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) or denintuzumab mafodotin plus RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) to assess the safety of these 2 combination regimens. Part B of the study is designed to evaluate the antitumor activity and safety of denintuzumab mafodotin in combination with either RCHOP or RCHP (Experimental Arm) compared with RCHOP alone (Comparator Arm).

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Treatment-naive patients with histologically confirmed systemic de novo or transformed diffuse large B-cell lymphoma (DLBCL) (from follicular or marginal zone lymphoma), or follicular lymphoma (FL) Grade 3b;

    • patients must have high intermediate or high risk disease
  • Tumor tissue available from most recent biopsy to determine cell of origin

  • Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease greater than 1.5cm diameter

  • Eastern Cooperative Oncology Group performance status ≤2

  • Age 18 years or older

  • Adequate study baseline laboratory parameters

Exclusion criteria

  • Previous history of treated indolent lymphoma
  • History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years
  • History of progressive multifocal leukoencephalopathy
  • Cerebral/meningeal disease related to the underlying malignancy
  • Patients with the following ocular conditions: corneal disorders, monocular vision (ie. best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 4 patient groups

denintuzumab mafodotin + RCHOP
Experimental group
Description:
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Treatment:
Drug: rituximab
Drug: vincristine
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone
Drug: denintuzumab mafodotin
denintuzumab mafodotin + RCHP
Experimental group
Description:
Part A: denintuzumab mafodotin (SGN-CD19A) + RCHP (rituximab, cyclophosphamide, doxorubicin, and prednisone)
Treatment:
Drug: rituximab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone
Drug: denintuzumab mafodotin
denintuzumab mafodotin + RCHOP or RCHP
Experimental group
Description:
Part B: denintuzumab mafodotin (SGN-CD19A) + RCHOP or RCHP
Treatment:
Drug: rituximab
Drug: vincristine
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone
Drug: denintuzumab mafodotin
RCHOP
Active Comparator group
Description:
Part B: RCHOP alone: (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
Treatment:
Drug: rituximab
Drug: vincristine
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone

Trial documents
2

Trial contacts and locations

35

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Data sourced from clinicaltrials.gov

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